510(k) K190809— Sample Imaging for Senographe Pristina

Substantially Equivalent

GE Healthcare

Clearance details

Applicant: GE Healthcare
Product code: Code MUE
Advisory panel: Radiology
Date received: 2019-03-29
Decision date: 2019-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buc, FR

Adverse events under product code MUE

product code MUE

Death: 5
Other: 1
Total: 6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.